Abstract:

Disclosed is an apparatus for the treatment of a wound on a patient. The
apparatus is capable of administering localized negative pressure therapy
to the wound using a negative pressure source and a drain line for
removing exudate from the wound. The apparatus is also capable of
administering localized hyperbaric fluid therapy to the wound using a
fluid source and a supply line for supplying fluid to the wound.

Claims:

1. A wound treatment apparatus comprising:a drain line configured for
attachment to a negative pressure source and for removing exudate from
the wound;a supply line configured for attachment to a fluid source and
for supplying fluid to the wound;a controller configured to:cause
negative pressure therapy to be administered to the wound via the drain
line, andcause hyperbaric fluid therapy to be administered to the wound
via the supply line for approximately 10 seconds to approximately 60
seconds.

2. The wound treatment apparatus of claim 1, wherein the controller is
further configured to selectively cause the administration of only
negative pressure therapy or only hyperbaric fluid therapy.

3. The wound treatment apparatus of claim 1, wherein the drain line is
configured for attachment to a hospital room suction line.

4. The wound treatment apparatus of claim 1, wherein the supply line is
configured for attachment to a hospital room oxygen line.

5. The wound treatment apparatus of claim 1 further comprising a
humidification device operatively connected to the supply line.

6. The wound treatment apparatus of claim 1, further comprising a negative
pressure source and the fluid source.

7. The wound treatment apparatus of claim 6, wherein the fluid source is
an oxygen canister.

8. The wound treatment apparatus of claim 6, wherein the negative pressure
source and fluid source share a power supply.

9. The wound treatment apparatus of claim 6, wherein the fluid source is
configured to supply a constant flow of fluid and the controller is
configured to cause the negative pressure source to operate
intermittently such that negative pressure therapy is administered to the
wound when the negative pressure source is on and hyperbaric fluid
therapy is administered to the wound when the negative pressure source is
off.

10. The wound treatment apparatus of claim 1, further comprising a
pressure sensor to measure pressure at the wound.

11. The wound treatment apparatus of claim 10, wherein the pressure sensor
is operatively connected to the controller and the controller is further
configured to adjust at least one of the negative pressure therapy or the
hyperbaric fluid therapy in response to information received from the
pressure sensor.

12. The wound treatment apparatus of claim 1 wherein the controller is
further configured to selectively cause the cessation of one of the
negative pressure therapy or the hyperbaric fluid therapy without causing
the cessation of the other of the negative pressure therapy or the
hyperbaric fluid therapy.

13. The wound treatment apparatus of claim 1, further comprising a
collection device operatively connected to the drain line to collect
exudate from the wound.

14. The wound treatment apparatus of claim 13, wherein the collection
device comprises a sensor for indicating the amount of exudate in the
collection device.

15. The wound treatment apparatus of claim 14, wherein the collection
device sensor is operatively connected to the controller and the
controller is further configured to stop the administration of negative
pressure therapy upon receiving information from the collection device
sensor indicating that the collection device is full.

16. The wound treatment apparatus of claim 1, further comprising a
mechanical pressure regulator connected to the supply line.

17. A portable wound treatment apparatus comprising:a negative pressure
source configured for operative engagement with a wound dressing via a
drain line;a fluid source configured for operative engagement with a
wound dressing via a supply line;a controller configured to:cause
negative pressure therapy to be administered to the wound, andcause
hyperbaric fluid therapy to be administered to the wound for
approximately 10 seconds to approximately 60 seconds; anda housing
configured to house the negative pressure source, the fluid source and
the controller.

18. The portable wound treatment apparatus of claim 17, further comprising
a power source for supplying power to at least one of the negative
pressure source and the fluid source, wherein the housing is further
configured to house the power source.

19. The portable wound treatment apparatus of claim 18, wherein the fluid
source is an oxygen concentrator, the negative pressure source is suction
device and the power source is a rechargeable battery.

20. A method for treating a wound comprising:applying to the wound a
dressing that engages a supply line and a drain line;connecting the
supply line to a fluid source;connecting the drain line to a negative
pressure source;administering negative pressure therapy to the wound via
the drain line; andadministering hyperbaric fluid therapy to the wound
for approximately 10 to approximately 60 seconds.

21. The method of claim 20, wherein the negative pressure therapy and the
hyperbaric fluid therapy are administered intermittently.

22. The method of claim 20, wherein negative pressure therapy is
administered immediately following the administration of hyperbaric fluid
therapy and hyperbaric fluid therapy is administered immediately
following the administration of negative pressure therapy.

[0002]The present invention relates generally to wound care treatment and
systems for treating wounds. More specifically, the present invention
relates to a system designed for alternating applications of vacuum and
hyperbaric wound treatments to a wound site.

[0003]The patient care industry is continually searching to provide better
services, reduce costs, and improve the equipment used to provide the
best possible care to the patients. One such way to advance patient care
is to improve the treatment of chronic and acute wounds and various types
of therapies to treat these wounds. One of two types of treatments is
often used to treat chronic and acute wounds: negative pressure therapy
or hyperbaric oxygen therapy.

[0004]Negative pressure therapy is the controlled application of
sub-atmospheric pressure to a wound using a therapy unit, such as a
vacuum or suction device, to expose a wound to negative pressure to help
promote wound healing. The wound is typically covered to facilitate this
negative pressure and suction at the wound area. Various types of
resilient, open cell foam surface dressings are typically sealed within
an adhesive drape to provide the sub-atmospheric pressure at the wound
site. The exudates drained from the wound site are normally directed to a
canister that stores the fluids and/or infectious material until properly
disposed. The negative pressure wound therapy has been typically
prescribed for chronic and acute wound types such as diabetic wounds,
pressure ulcers, abdominal wounds, trauma wounds, various burns, flaps
and grafts. One of the limitations of negative pressure therapy is that
it may be less effective on patients with vascular disorders, such as
diabetes, particularly because negative pressure therapy creates a
hypoxic environment at the wound. Current research indicates that wound
healing is impaired when the oxygen level is 30 millimeters of mercury
(mmHg) or less.

[0005]Hyperbaric oxygen therapy is the controlled application of
greater-than-atmospheric pressures of oxygen to a wound. Oxygen is
typically required for all new cell growth, and chronic or nonhealing
wounds tend to exhibit low oxygen tensions, or tend to be ischemic. A
wound can become dormant if the amount of wound tissue that is poorly
oxygenated reaches a critical mass. In this state, the body may no longer
recognize the need to heal that area, which exacerbates the lack of
oxygen in that wound and thus substantially prevents healing of the wound
by the body. Oxygen therapy is particularly useful for patients with poor
circulation. In addition to helping kill bacteria, oxygen applied to an
open wound at a hyperbaric level is dissolved into the wound and absorbed
by the surface wound tissue. The cells of the wound tissue that absorb
the oxygen will begin metabolic activity in response to the increased
oxygen tension. Once the oxygen source is removed, the previously active
cells request more oxygen from the body. The body responds by beginning
to form new blood cells, and thus, starting the healing process.

[0006]Typically, hyperbaric oxygen therapy is performed by placing the
patient into a hyperbaric chamber that encompasses the full body of the
patient or an entire extremity, such as a leg or an arm. Such chambers
are problematic due to their lack of portability, the difficulty in
sterilization of the chambers between patients, and the potential adverse
effects of breathing oxygen at hyperbaric pressure. It would be
preferable if the hyperbaric oxygen treatment were localized at the wound
rather than applied to the patient's entire body or extremity.

[0007]While both negative pressure and hyperbaric oxygen therapies are
each believed to be effective when administered as separate wound care
treatments, many patients may benefit from a treatment plan incorporating
both negative pressure and hyperbaric oxygen therapies. Because existing
hyperbaric oxygen treatment is typically performed in a hyperbaric
chamber, switching between negative pressure therapy and hyperbaric
oxygen therapy is a long process. Before entering a hyperbaric oxygen
chamber, a patient would first have to be disconnected from the negative
therapy device and the negative pressure therapy dressing--which
typically includes packing materials, a drain, tubing, and sealing
material--would have to be removed. Then, following hyperbaric oxygen
treatment, a new negative pressure dressing would have to be applied.
These procedures are wasteful and time-consuming, making it difficult, if
not impossible, to alternate between negative pressure therapy and
hyperbaric oxygen therapy every few minutes or less.

[0008]It would be preferable if an apparatus were capable of localized
alternating administration of negative pressure and hyperbaric oxygen
therapies to treat a single wound without requiring a change of dressing.

BRIEF SUMMARY OF THE INVENTION

[0009]Disclosed is an apparatus for the treatment of a wound on a patient.
The apparatus includes a drain line configured for attachment to a
negative pressure source and for removing exudate from the wound; a
supply line configured for attachment to a fluid source and for supplying
fluid to the wound; and a controller. The controller is configured to
cause negative pressure therapy to be administered to the wound via the
drain line. The controller is further configured to cause hyperbaric
fluid therapy to be administered to the wound via the supply line.

[0010]The controller is further configured to cause hyperbaric fluid
therapy to be administered to the wound at an absolute pressure of at
least approximately 1.5 atmospheres via the supply line.

[0011]Also disclosed is a wound treatment apparatus that includes a drain
line configured for attachment to a negative pressure source and for
removing exudate from the wound. The apparatus further includes a supply
line configured for attachment to a fluid source and for supplying fluid
to the wound and a controller. The controller is configured to cause
negative pressure therapy to be administered to the wound for a first
time period via the drain line, and cause hyperbaric fluid therapy to be
administered to the wound for a second time period via the supply line,
wherein the first time period is approximately two to three times as long
as the second time period.

[0012]Also disclosed is a portable wound treatment apparatus. The portable
wound treatment apparatus includes a negative pressure source configured
for operative engagement with a wound dressing via a drain line and a
fluid source configured for operative engagement with a wound dressing
via a supply line. The apparatus also includes a controller that is
configured to cause negative pressure therapy to be administered to the
wound, and also to cause hyperbaric fluid therapy to be administered to
the wound at an absolute pressure of at least approximately 1.5
atmospheres. The apparatus further includes a housing configured to house
the negative pressure source, the fluid source and the controller.

[0013]Further disclosed is a portable wound treatment apparatus including
a negative pressure source configured for operative engagement with a
wound dressing via a drain line. The apparatus also includes a fluid
source configured for operative engagement with a wound dressing via a
supply line, a controller and a housing configured to house the negative
pressure source, the fluid source and the controller. The controller is
configured to cause negative pressure therapy to be administered for a to
the wound first time period, and cause hyperbaric fluid therapy to be
administered to the wound for a second time period, wherein the first
time period is approximately two to three times as long as the second
time period.

[0014]Also disclosed is a wound treatment apparatus comprising including a
drain line configured for attachment to a negative pressure source and
for removing exudate from the wound and a supply line configured for
attachment to a fluid source and for supplying fluid to the wound. The
apparatus further includes a controller that is configured to cause
negative pressure therapy to be administered to the wound via the drain
line, and to cause hyperbaric fluid therapy to be administered to the
wound at via the supply line. The controller is further configured to
control the administration of negative pressure therapy and hyperbaric
fluid therapy such that the administration of negative pressure therapy
and hyperbaric fluid therapy is cyclical and the hyperbaric fluid therapy
is administered to the wound for no more than 30 minutes during each
cycle.

[0015]Also disclosed is a method for treating a wound. The method includes
applying to the wound a dressing that engages a supply line and a drain
line; connecting the supply line to a fluid source; connecting the drain
line to a negative pressure source; administering negative pressure
therapy to the wound via the supply line; and administering hyperbaric
fluid therapy to the wound at an absolute pressure of at least 1.5
atmospheres via the supply line.

[0016]Further disclosed is another method for treating a wound. The method
includes applying to the wound a dressing that engages a supply line and
a drain line; connecting the supply line to a fluid source; connecting
the drain line to a negative pressure source; administering negative
pressure therapy to the wound via the drain line for a first time period;
and administering hyperbaric fluid therapy to the wound via the supply
line for a second time period. The first time period is approximately two
to three times as long as the second time period.

[0017]Also disclosed is a method for treating a wound comprising: applying
to the wound a dressing that engages a supply line and a drain line;
connecting the supply line to a fluid source; connecting the drain line
to a negative pressure source; administering negative pressure therapy to
the wound via the drain line for a first time period; following the
administration of negative pressure therapy, administering hyperbaric
fluid therapy to the wound via the supply line for no more than 30
minutes; and following the administration of hyperbaric fluid therapy,
administering negative pressure therapy to the wound via the drain line.

[0019]The fluid source may be configured to supply a constant flow of
fluid such that the administration of negative pressure therapy is
accomplished by activating the negative pressure source and the
administration of hyperbaric fluid therapy is accomplished by
deactivating the negative pressure source.

[0020]The administration of negative pressure therapy may also be
accomplished by activating the negative pressure source and reducing the
flow of fluid from the fluid source. Similarly, the administration of
hyperbaric fluid therapy may be accomplished by deactivating the negative
pressure source and increasing the flow of fluid from the hyperbaric
fluid source.

[0021]The administration of negative pressure therapy and hyperbaric fluid
therapy may also be adjusted in response to information received from a
sensor, such as a diffusion sensor, that measures tissue conditions at
the wound.

[0022]In addition, the disclosed apparatus may also include either
mechanical or electronic pressure regulation to ensure that the pressures
applied to the wound site do not exceed a desired level.

[0023]Also disclosed is a method for preparing a wound dressing. The
method includes inserting packing material into the wound; inserting open
ends of a supply line and a drain line into the wound; molding a pliable
adhesive around the perimeter of the wound such that the adhesive
separates the supply line from the skin surrounding the wound and such
that the adhesive separates the drain line from the skin surrounding the
wound; molding another piece of pliable adhesive over the supply line and
the drain line; and placing sealing material over the wound, the packing
material, the supply line, the drain line and the adhesive such that the
sealing material adheres to both the adhesive and the skin surrounding
the adhesive.

[0024]It is therefore a general object of the present invention to provide
an improved apparatus for the treatment of wounds.

[0025]Another object of the present invention is to provide an apparatus
that provides both negative pressure therapy and hyperbaric fluid therapy
to a wound site.

[0026]These and further features of the present invention will be apparent
with reference to the following description and attached drawings. In the
description and drawings, particular embodiments of the invention have
been disclosed in detail as being indicative of some of the ways in which
the principles of the invention may be employed, but it is understood
that the invention is not limited correspondingly in scope. Rather, the
invention includes all changes, modifications and equivalents coming
within the spirit and terms of the claims appended hereto.

[0027]Features that are described and/or illustrated with respect to one
embodiment may be used in the same way or in a similar way in one or more
other embodiments and/or in combination with or instead of the features
of the other embodiments.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0028]FIG. 1 is a schematic view of an apparatus made in accordance with
the current disclosure;

[0029]FIG. 2 is a schematic illustration of an example wound dressing and
surrounding elements made in accordance with the current disclosure;

[0030]FIG. 3 is a schematic illustration of a hospital bed embodiment of
apparatus made in accordance with the current disclosure;

[0031]FIG. 4 is an embodiment of a portable apparatus made in accordance
with the current disclosure positioned on a wound;

[0032]FIG. 5 is an alternate embodiment of an apparatus made in accordance
with the current disclosure positioned on a wound;

[0033]FIG. 6 is a side view of a wound being treated by an apparatus made
in accordance with the current disclosure and using an embodiment of a
drain made in accordance with the current disclosure;

[0034]FIG. 7 is top view of a wound being treated using the drain of FIG.
6;

[0036]FIG. 9 is an embodiment of the supply and drain lines made in
accordance with the current disclosure;

[0037]FIGS. 10A-F illustrate the preparation of a wound dressing made in
accordance with the current disclosure; and

[0038]FIG. 11 is a flow chart illustrating a method performed in
accordance with the current disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0039]The invention relates to a novel therapeutic method and apparatus
capable of administering both negative pressure therapy and hyperbaric
fluid therapy for wound healing. Preferably, negative pressure therapy
and hyperbaric fluid therapy, such as hyperbaric oxygen, are
intermittently applied to the wound area to remove exudate from the wound
and to infuse oxygen into the wound. It is believed that the controlled
application of these therapies can greatly increase wound healing
success, both clinically and aesthetically, and minimize wound healing
time

[0040]The apparatus includes a drain line that attaches to a negative
pressure source and is used to remove exudate from the wound. The
apparatus also includes a supply line that attaches to a fluid source,
such as an oxygen source, and is used to supply fluid to the wound under
positive pressure. The system further includes a controller that controls
the administration of negative pressure therapy via the drain line and
the administration of hyperbaric fluid therapy via the supply line. The
apparatus is thus capable of alternating between negative pressure
therapy and hyperbaric fluid therapy in an automated manner without
requiring clinician assistance and without necessitating a wound dressing
change. Moreover, the apparatus can also be made portable because it
provides localized therapy without requiring a chamber encompassing a
patient's entire body or extremity.

[0041]Monitoring of the therapy results, such as monitoring of oxygen
levels at the wound site or monitoring of exudate removal, allows the
wound treatment therapy to be tailored to each individual to maximize the
therapeutic effect while minimizing therapy duration.

[0042]Referring generally now to FIG. 1, a wound treatment apparatus 10
according to the present invention is illustrated schematically. The
apparatus 10 includes a drain line 18 that is attached to a negative
pressure source 14. The drain line 18 is preferably positioned to remove
exudates from the wound 12. The apparatus 10 also includes a supply line
20 that is attached to a fluid source 16. The supply line 20 is
preferably positioned to supply fluid to the wound 12. A controller 22
functions to control the therapy administered by the wound treatment
apparatus 10 to the wound 12.

[0043]As will be understood by those skilled in the art, the controller 22
may be implemented as a control system or even as a control circuit, such
as one or more of the following: programmable circuit, integrated
circuit, memory and I/O circuits, an application specific integrated
circuit, microcontroller, complex programmable logic device, field
programmable gate arrays, other programmable circuits, or the like.

[0044]The controller 22 can cause the wound treatment apparatus 10 to
administer negative pressure therapy to the wound 12 via the drain line
18. The controller 22 can also cause the wound treatment apparatus 10 to
administer hyperbaric fluid therapy to wound 12 via the supply line 20.
Preferably, hyperbaric fluid therapy is administered to the wound 12 at
an absolute pressure of at least approximately 1.5 atmospheres.

[0045]In operation, negative pressure therapy and hyperbaric oxygen
therapy may each be administered intermittently. In other words, negative
pressure therapy and hyperbaric fluid therapy may be administered in
alternating treatments where the wound treatment apparatus 10 cycles
between negative pressure therapy and hyperbaric fluid therapy or, only
one type of treatment (i.e. negative pressure therapy or hyperbaric fluid
therapy) may be administered in an intermittent manner such that the
wound treatment apparatus 10 cycles between administering treatment to
the wound 12 and not administering treatment to the wound 12.

[0046]For example, controller 22 may be configured to cause negative
pressure therapy to be administered to the wound 12 via the drain line 18
for a first time period and hyperbaric fluid therapy to be administered
to the wound 12 via the supply line 20 for a second time period. In one
presently preferred embodiment, the first time period during which
negative pressure therapy is administered is approximately two to three
times as long as the second time period during which hyperbaric fluid
therapy is administered. The controller 22 may be further configured to
cause hyperbaric fluid therapy to be administered immediately following
the cessation of the administration of negative pressure therapy and to
cause negative pressure therapy to be administered immediately following
the cessation of the administration of hyperbaric fluid therapy.

[0047]The administration of negative pressure therapy and hyperbaric fluid
therapy may be controlled using a variety of methods. For example, the
fluid source 16 may be configured to supply a constant flow of fluid. The
controller 22 may be configured to cause the administration of negative
pressure therapy by activating the negative pressure source 14, which
would create a negative pressure environment at the wound 12 even though
the wound 12 would continue to be exposed to fluid from the fluid source
16. The controller 22 may be further configured to cause the
administration of hyperbaric fluid therapy by deactivating the negative
pressure source 14, thereby causing the wound 12 to be exposed only to
the fluid from the fluid source 16 and causing pressures at the wound 12
to build to hyperbaric levels determined by, among other factors, the
flow rate of the fluid.

[0048]Another mechanism for controlling the administration of negative
pressure therapy and hyperbaric fluid therapy is to use the controller 22
to control both the negative pressure source 14 and the fluid source 16.
Thus, the controller 22 may be configured to cause the administration of
negative pressure therapy by activating the negative pressure source 14
and either reducing the flow from or deactivating the fluid source 16.
Similarly, the controller 22 may be further configured to cause the
administration of hyperbaric fluid therapy by deactivating the negative
pressure source 14 and increasing the flow of fluid from the fluid source
16.

[0049]Alternatively, the controller 22 may include two controllers, one
for each device. The controller that controls the fluid source 16 may be
configured to detect the state of the negative pressure source 14 or the
state of the environment surrounding the wound 12. Upon determining an
end of a negative pressure therapy cycle, the controller controlling the
fluid source 16 could cause the administration of hyperbaric fluid
therapy by activating or increasing the fluid flow from the fluid source
16. Conversely, the controller that controls the negative pressure source
14 could be configured to detect the state of the fluid source 16 or the
state of the environment surrounding the wound 12. Upon determining an
end of a hyperbaric fluid therapy cycle, the controller controlling the
negative pressure source 14 could cause the administration of negative
pressure therapy by activating the negative pressure source 14.

[0050]While each of the negative pressure therapy and the hyperbaric fluid
therapy could potentially be administered to the wound 12 for hours
before alternating to the other therapy, it is presently preferred that
the controller 22 cause negative pressure therapy to be administered to
the wound 12 for relatively short periods of time. For example, negative
pressure therapy may be administered for approximately 20 seconds to
approximately 180 seconds before moving on to hyperbaric fluid therapy or
to non-therapy in the event that the apparatus is set to intermittently
apply only negative pressure therapy. Similarly, the controller 22 may
cause hyperbaric fluid therapy to be administered to the wound 12 for
approximately 10 seconds to approximately 60 seconds before moving on to
negative pressure therapy or to non-therapy in the event that the
apparatus is set to intermittently apply only hyperbaric pressure
therapy.

[0051]Moreover, the negative pressure therapy and the hyperbaric fluid
therapy may be administered in a cyclical manner. For each cycle
consisting of negative pressure therapy administration and hyperbaric
fluid therapy administration, the administration of hyperbaric fluid
therapy may be limited to no more than 30 minutes. In other words,
following the administration of negative pressure therapy for a first
time period, hyperbaric fluid therapy is administered for no more than 30
minutes, after which the negative pressure therapy is administered again
for some time period, which may be the same as the first time period.
Hyperbaric fluid therapy would then preferably be administered again for
no more than 30 minutes, after which negative pressure therapy would be
administered again.

[0052]In addition, the controller 22 may also be capable of selectively
causing the cessation of negative pressure therapy without causing the
cessation of the hyperbaric fluid therapy. Similarly, the controller 22
is preferably configured to be capable of selectively causing the
cessation of hyperbaric fluid therapy without causing the cessation of
the negative pressure therapy.

[0053]As will be understood by those of skill in the art, the
administration of negative pressure therapy generally involves exposing
the wound 12 to pressures of less than 1 atmosphere. The pressures
employed during negative pressure therapy may include absolute pressures
ranging from approximately 0 mmHg to approximately 300 mmHg. Preferably,
the absolute pressure ranges from approximately 60 mmHg to approximately
160 mmHg during the administration of negative pressure therapy.

[0054]As will also be understood by those of skill in the art, the
administration of hyperbaric fluid therapy involves exposing the wound 12
to a fluid at greater than atmospheric pressures. Preferably, the wound
12 is subjected to an absolute pressure ranging from approximately 1.5
atmospheres to approximately 3 atmospheres during the administration of
hyperbaric fluid therapy.

[0055]The negative pressure source 14 can be any suitable suction device
such as a vacuum, a manual, mechanical, or electrical pump, a hospital
room suction line, or any other device exhibiting vacuum or suction
capabilities. The fluid source 16 can be a suitable fluid supply device
and preferably is an oxygen source or a humidified oxygen source, such as
an oxygen concentrator, oxygen canister, or oxygen supplied from a
hospital room oxygen line. For example, the fluid source 16 may
administer oxygen or humidified oxygen at approximately 0.1 liters per
minute to approximately 3 liters per minute. Preferably, the fluid source
16 administers oxygen or humidified oxygen at approximately 1 liter per
minute to approximately 2 liters per minute.

[0056]Also, the negative pressure source 14 and the fluid source 16 may be
powered by a single power source, such as a wall plug or a rechargeable
battery, and may share a power supply, such as power supply 23. Further,
the negative pressure source 14 and the fluid source 16 may both reside
in a single portable casing that houses the negative pressure source 14
and the fluid source 16 as one unit.

[0057]The drain line 18 may be surgical tubing, oxygen tubing or any other
suitable type of line for removing exudate from a wound site. The supply
line 20 may be surgical tubing, oxygen tubing or any other suitable type
of line for carrying fluid, such as oxygen, to a wound site. In addition,
part of the drain line 18 and part of the supply line 20 may be formed by
a multi-lumen tube.

[0058]To perform localized administration of negative pressure therapy and
hyperbaric fluid therapy, the drain line 18 and supply line 20 preferably
engage a wound dressing. FIG. 2 is a schematic illustration of an example
wound dressing and surrounding elements made in accordance with the
current disclosure. As shown in FIG. 2, the dressing includes packing
material 42 above the wound 12 and a drain 24 atop the packing material
42. The packing material may be, for example, gauze, foam
dressing/packing, sponges, or the like. Preferably, the packing material
is anti-microbial gauze saturated with saline.

[0059]The drain device 24 may be included as part of the drain line 18 or
attached to the end of the drain line 18 opposite the negative pressure
source 14. Suitable drain devices include Jackson-Pratt silicon drain,
flat drain, round channel drain, fluted drain, drain tube, Kremlin drain,
or other drains capable of removing exudates from within or on top of the
wound 12. An example of a drain 24 is illustrated in FIGS. 6-8.

[0060]Atop the drain 24 is more packing material 42. The dressing further
has a gasket 41 made from pliable adhesive material molded around the
surrounding edge of the wound 12. The drain line 18 and the supply line
20 are atop the gasket 41. Optionally, additional gasket 41 material is
included atop the drain line 18 and supply line 20 for engaging the drain
line 18 and the supply line 20. The gasket 41 material may be, for
example, an Eakin Cohesive Seal.

[0061]Sealing material 40 surrounds the wound 12, the drain 24, the
packing material 42 and the gasket 41. The sealing material 40 can adhere
to the gasket 41 and the skin surrounding the wound 12. Preferably, the
dressing is capable of maintaining adherence during administration of
hyperbaric fluid therapy at pressures of at least 3 atmospheres. The
sealing material 40 preferably has adhesive properties to withstand the
pressure induced by the supply of hyperbaric fluid from the fluid source
16 and the negative pressures drawn by the negative pressure source 14.

[0062]It will be understood by those skilled in the art that various types
of dressings may be used. For example, the drain 24 may be positioned
above the packing material 42 or below the packing material 42, as
opposed to sandwiched between packing material 42 as shown. Also, the
drain 42 and sealing material 40 may be incorporated as one device. In
addition, the dressing may also include a protective mesh separating the
packing material 42 from the wound 12.

[0063]Turning next to FIG. 3, a schematic illustration of a hospital bed
embodiment of apparatus made in accordance with the current disclosure is
provided. Because of the presence of both a negative pressure supply 14
and a fluid supply 16 in many hospital rooms, it may be desirable to
incorporate the controller 22 into a hospital bed 25, which may include
the bed frame and/or the mattress. Thus, the controller 22 in a hospital
bed 25 is preferably used to administer negative pressure therapy and
hyperbaric pressure therapy on a wound 12 using a hospital room suction
line as the negative pressure source 14 and the hospital room oxygen line
as the fluid source 16. To control the pressures at the wound, the
apparatus further includes valves 27a and 27b that are and located on the
drain line 18 and supply line 20 and controlled in an automated manner by
the controller 22. The apparatus may further include sensors to provide
the controller 22 with information used by the controller 22 in
controlling the valves 27 and 27b.

[0064]Turning next to FIG. 4, a portable wound treatment apparatus 10 made
in accordance with the current disclosure and positioned on a wound 12 is
illustrated schematically. Like FIGS. 1 and 3, FIG. 4 includes a negative
pressure source 14, a fluid source 16, a controller 22, drain line 18 and
supply line 20. Attached to the drain line 18 is a drain 24 placed in the
wound 12. A dressing including packing material 42 and a sealing material
40 is placed over the wound 12 and adhered to the skin 11.

[0065]To make the apparatus of FIG. 3 portable, the negative pressure
source 14, the controller 22 and the fluid source 16 are positioned in a
housing 36 to house the negative pressure source 14 and the fluid source
16 as a single unit. The housing 36 may also house the collection device
26 and a humidification device, such as the humidification device 38 of
FIG. 5. The humidification device 38 may be connected to the supply line
20 to add moisture to fluid being supplied to the wound 12. In addition,
it may be desirable to include a power source 39, such as a rechargeable
battery, within the housing 36. The power source 39 may run both negative
pressure source 14 and the fluid source 16. The casing 36 may further
include a handle 37 used to transport the apparatus 10 and/or suspend the
apparatus 10 on a medical support such as an IV stand.

[0066]The drain 24, in conjunction with the drain line 18 under operation
of the negative pressure source 14, may operate to transport exudates
from the wound 12 to a collection device 26 connected to the drain line
18. The exudates can be stored in the collection device 26 until properly
disposed of.

[0067]Turning next to FIG. 5, another embodiment of a wound treatment
apparatus 10 made in accordance with the current disclosure and
positioned on a wound is illustrated schematically. Like FIGS. 1, 3 and
4, FIG. 5 includes a negative pressure source 14, a fluid source 16, a
controller 22, a drain line 18 and a supply line 20. Attached to the
drain line 18 is a drain 24 placed in the wound 12. A dressing including
packing material 42 and a sealing material 40 is placed over the wound 12
and adhered to the skin 11. Following placement, the sealing material 40
may create a fluidic chamber around the wound 12.

[0068]The apparatus of FIG. 5 also includes a collection device 26
connected to the drain line 18 for storing exudates from the wound 12
until properly disposed of. As shown, the drain line 18 includes a drain
line connection end 19 and the collection device 26 includes a drain line
portal 15 shaped to accept the drain line connection end 19. Preferably,
the drain line portal 15 is shaped to accept only the drain line
connection end 19 so as to avoid unintentionally connecting the supply
line 20 to the drain collection device 26. The collection device 26 may
also include a collection device sensor 28 engaging the collection device
26 and connected to the controller 22 to indicate the level to which the
collection device 26 is filled with exudates. The controller 22 may be
configured to stop the administration of negative pressure therapy upon
receiving information from the collection device sensor indicating that
the collection device is full. In one embodiment, the collection device
sensor 28 may notify the controller 22 and a warning can be issued to the
user and/or the apparatus 10 can be shut down.

[0069]The supply line 20 supplies fluid to the wound site. Preferably,
fluid supply 16 has a supply line portal 17 that is shaped to accept only
a supply line connection end 21 so as to avoid unintentionally connecting
the drain line 18 to the fluid source 16. The wound treatment apparatus
10 may also include a pressure regulator to help prevent excessive
pressurization of the wound site. The pressure regulator may be, for
example, a pressure sensor 44, which can be positioned to determine the
pressure at the wound site. For example, the pressure sensor 44 may be
positioned at the wound site or anywhere along the pathway between the
fluid source 16 and the wound 12 or anywhere along the pathway between
the negative pressure source 14 and the wound 12. The pressure sensor 44
may be any type of device capable of providing information to either a
user or the controller 22 about the pressure at the wound site. The
pressure sensor 44 may be operatively connected to the controller 22 and
the controller 22 may be configured to adjust the negative pressure
therapy or the hyperbaric fluid therapy in response to information
received from the pressure sensor 44.

[0070]The pressure regulator may also be a mechanical pressure regulator
30 positioned along the supply line 20 between the wound 12 and fluid
supply 16. The mechanical pressure regulator 30 may be used in
conjunction with the pressure sensor 44. The mechanical pressure
regulator 30 is preferably configured to actuate when the pressure in the
supply line 20 at the pressure regulator 30 exceeds a set threshold. The
actuation of the mechanical pressure regulator 30 causes a reduction of
the supply line 20 pressure. For example, the mechanical pressure
regulator 30 may include a release valve that opens when the pressure
within the supply line 20 exceeds a certain threshold.

[0071]One embodiment of the mechanical pressure regulator 30 is
illustrated in FIG. 9. As shown, the mechanical pressure regulator 30 is
a Y valve. One side of the Y valve has a wound connection line 34 that is
operatively connected to the wound 12. The opposite side of the Y valve
has two pathways. One of the pathways has a release valve 33 for venting
excess fluid. The other pathway has a fluid source connection line 32 for
connecting the mechanical pressure regulator 30 to the fluid source 16.
The mechanical pressure regulator 30 is preferably configured to actuate
when the pressure at the mechanical pressure regulator 30 exceeds a set
threshold. Actuation of the mechanical pressure regulator 30 causes the
release valve 33 to open. The set threshold may be determined by the
desired pressure to be applied to the wound 12 during hyperbaric fluid
therapy. The actuation of the mechanical pressure regulator 30 then
causes a reduction of the supply line 20 pressure as fluid is vented out
of the system.

[0072]In addition, the mechanical pressure regulator 30 may be configured
to maintain a reduced pressure within the supply line 20 following the
actuation of the mechanical pressure regulator 30. While the venting of
fluid may cause a reduction in the supply line 20 pressure, the system
may equalize if the flow rate of the fluid through the supply line 20
remains constant and the release valve 33 remains open. Thus, the
mechanical pressure regulator 30 causes the pressure in the supply line
20 to be maintained at a reduced level.

[0073]Also as shown in FIG. 9, the Y valve 50 may connect the drain line
18 and the supply line 20 into a single-lumen tube for engaging the
dressing. The Y valve 50 includes a drain connection line 54 and supply
connection line 56. The supply line 20 and drain line 18 are merged
together by the Y valve 50 and the merged supply line 20 and drain line
18 are engageable with the wound 12 via the wound connection 52.

[0074]Also as shown in FIG. 5, the wound treatment apparatus may also
include humidification device 38 operatively connected the supply line
20. The humidification device 38 may be configured to humidify the fluid
from the fluid source 16 before the fluid is administered to the wound
12. For example, when the fluid source 16 supplies oxygen, the
humidification device 38 may function to humidify the oxygen so that
humidified oxygen is supplied to the wound 12. In addition, the
humidification device 38 may be configured to heat the fluid in the
supply line 20, thereby causing an increase in the temperature at the
wound 12. Accordingly, the humidification device 38 may comprise a
heating element 46 that is operatively connected to the controller 22.
Alternatively, a heating element 46 may be a component of the apparatus
10 that is separate from the humidification device 38. In operation, the
controller 22 may be configured to cause the heating element 46 to
maintain a temperature at the wound 12 above approximately 98 degrees
Fahrenheit and below the combustion temperature of the fluid administered
during hyperbaric fluid therapy. Also, the heating element 46 may be
configured to control the temperature at the wound independent of the
controller 22.

[0075]The humidification device 38 may also act as a drug delivery device.
For example, the humidification device 38 may function to introduce at
least one non-oxygen drug into the supply line 20. The non-oxygen drug
may be introduced into the humidification device 38 in powder form and
may be supplied by the humidification device 38 to the supply line 20 in
powder form via gas. The non-oxygen drug may also be supplied in vapor
form via humidified gas. Alternatively, a separate drug delivery device
may be attached to the supply line 20 to deliver non-oxygen drugs to the
wound 12.

[0076]Also as shown in FIG. 5, the wound treatment apparatus may further
include a diffusion sensor 45 to measure diffusion of fluid, such as
oxygen, into the wound 12. The diffusion sensor 45 may be, for example, a
transcutaneous oxygen sensor. The diffusion sensor 45 is preferably
operably connected to the controller 22 and the controller 22 is
preferably configured to adjust at least one of the negative pressure
therapy or the hyperbaric fluid therapy in response to information
received from the diffusion sensor 45. For example, in response to
information received from the diffusion sensor 45 indicating that the
fluid diffusion rate is below a desired level, the controller 22 may be
configured to cause an increase in at least one of the fluid flow rate or
the pressure at the wound 12 during hyperbaric fluid therapy.

[0077]The controller 22 may also or alternatively be configured to cause
an increase in the duration of the administration of hyperbaric fluid
therapy relative to the negative pressure therapy in response to
information received from the diffusion sensor 45. Similarly, the
controller 22 may be configured to cause a decrease in the duration of
the administration of negative pressure therapy relative to the
hyperbaric fluid therapy in response to information received from the
diffusion sensor 45 indicating that the fluid diffusion rate is below a
desired level.

[0078]In another embodiment the supply line 20 has a supply line
connection end 21 while the fluid source 16 includes a supply line portal
17. The supply line portal 17 is shaped to accept the supply line
connection end 21. The drain line 18 includes a drain line connection end
19 while the collection device 26 includes a drain line portal 15 shaped
to accept the drain line connection end 19. The supply line portal 17 is
shaped such that it will only accept the supply line connection end 21
while the drain line portal 15 is shaped to only accept the drain line
connection end 19. This configuration assists in the safe connection of
the negative pressure source 14 and fluid source 16 to the proper lines
18 and 20.

[0079]The apparatus 10 can include various disposable elements and still
maintain the inventive nature disclosed herein. For example, the drain
line 18 and supply line 20 as well as the collection device 26, or the
container that collects the exudants, the sealing material 40, packing
material 42 and other elements that are in or near the wound 12 can be
made to be disposable and discarded between uses of the remainder of the
apparatus 10 to facilitate sterilization and reduce the potential
contamination of subsequent patients by infectious diseases.

[0080]Assembly of the apparatus 10 and engagement of the apparatus 10 to a
wound 12 can be accomplished as follows. The packing material 42 can be
positioned in and around the wound to take up empty space thereby. A
drain device 24 can be positioned in and around the wound 12 and
connected to the drain line 18. The drain line connection end 19 can be
attached to the negative pressure source 14 in the drain line portal 15.
The drain line 18 can alternately go through a separate collection device
26 that will collect the exudates from the wound 12. The supply line 20
can also be positioned in or near the wound 12 while the supply line
connection end 21 can be inserted into the supply line portal 17 of the
fluid source 16. Alternatively the supply line 20 can be connected to a
humidification device 38 that will add moisture to the oxygen as it flows
to the wound 12.

[0081]Turning next to FIGS. 10A-F and 11, the preparation of one
embodiment of a wound dressing made in accordance with the current
disclosure is illustrated schematically and in flow chart form. As shown
in FIG. 10A and process block 1102, packing material 42 is inserted into
the wound 12. The packing material 42 preferably comprises anti-microbial
gauze saturated with saline. Prior to inserting the packing material 42,
it may be desirable to insert a protective mesh into the wound 12. Open
ends of the supply line 20 and drain line 18 are then inserted into the
wound 12 atop the packing material 42. This is illustrated in FIG. 10A
and process block 1104. As shown, the process of inserting open ends of
the supply line 20 and drain line 18 may involve inserting into the wound
12 a drain 24 connected to the supply line 20 and drain line 18. A
multi-lumen tube may form the supply line 20 and the drain line 18.
Preferably, additional packing material 42 is inserted atop the drain 24
as shown in FIG. 10B. An example of a drain 24 is illustrated in FIGS.
6-8.

[0082]As shown in FIG. 10c and process block 1106, a pliable adhesive
gasket 41 is molded around the perimeter of the wound 12. Preferably, the
gasket 41 separates supply line 20 and drain line 18 from the patient's
skin surrounding the wound 12. The supply line 20 and the drain line 18
are thus engaged with adhesive gasket 41. Preferably, as shown in FIG.
10C and process block 1108, another piece of a pliable adhesive gasket 41
is then molded over the supply line 20 and the drain line 18 to
strengthen the engagement. The pliable adhesive gasket 41 may be made
from a cohesive seal.

[0083]As shown in FIG. 10D and process block 1110, sealing material 40 is
then placed over the wound 12, the packing material 42, the supply line
20, the drain line 18 and the adhesive gasket 41 such that the sealing
material 40 adheres to both the adhesive gasket 41 and the skin
surrounding the adhesive. FIGS. 10E and 10F show the dressing during
hyperbaric pressure therapy and negative pressure therapy, respectively.

[0084]Although the invention has been shown and described with respect to
certain embodiments, it is obvious that equivalents and modifications
will occur to others skilled in the art upon the reading and
understanding of the specification. The present invention includes all
such equivalents and modifications, and is limited only by the scope of
the following claims.